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August 29, 2021
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Early rhythm control therapy for AF consistent regardless of presence of symptoms

The benefits of early, systematic rhythm control therapy were consistent regardless of whether patients had asymptomatic or symptomatic AF, according to new data from the EAST-AFNET 4 trial.

“The presence or absence of symptoms should not influence the decision for rhythm control therapy in patients with recently diagnosed atrial fibrillation and concomitant cardiovascular conditions,” Stephan Willems, cardiologist at Asklepios Hospital St. Georg, Hamburg, Germany, said at a press conference during the European Society of Cardiology Congress.

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As Healio previously reported, main results of the EAST-AFNET 4 trial demonstrated that initiation of rhythm control therapy within 1 year of AF diagnosis in patients at risk for stroke lowered risk for CV events compared with usual care, according to data presented at the 2020 ESC Congress.

Willems presented results of a new prespecified analysis of the trial that focused on the effects of early rhythm control therapy in patients with asymptomatic AF compared with symptomatic AF. The analysis involved 801 patients with asymptomatic AF (European Heart Rhythm Association [EHRA] score I; mean age, 71 years) and 1,832 patients with symptomatic AF, most of whom presented with mild or moderate symptoms (EHRA score II).

Those initially asymptomatic baseline were more likely to be older (P = .002), men (P < .001), have a higher CHA2DS2-VASc score (P < .001) and have a lower incidence of HF (P < .001).

Patients with asymptomatic AF who were randomly assigned to receive early rhythm control received similar therapies to those patients who were symptomatic. At 24 months, 19% of asymptomatic patients and 19.3% of symptomatic patients received AF ablation (P = .672). Moreover, anticoagulation used and treatment of concomitant CV conditions were similar regardless of absence or presence of symptoms.

The primary outcome of CV death, stroke, HF hospitalization or ACS occurred in 79 of 395 asymptomatic patients in the early rhythm control group and 97 of 406 asymptomatic patients in the usual care group (HR = 0.76; 95% CI, 0.6-1.03) over 8 years since randomization. According to the researchers, the cumulative incidence of the primary outcome in asymptomatic patients was almost identical to that observed in the overall trial, as well as in symptomatic patients in this analysis (HR = 0.79; 95% CI, 0.64-0.98; P for interaction = .848).

At 24 months, changes in measures of quality of life did were not different among patients with or without symptoms.

In addition, safety outcomes among asymptomatic patients were similar to those observed in asymptomatic patients, including mortality and stroke. Serious adverse events were rare and not affected by symptom status, according to the researchers.

Only 20% of patients who were initially asymptomatic at the start of the trial became symptomatic in the first 24 months of follow-up, while about 60% of those who were initially symptomatic became asymptomatic during 24 months of follow-up. This was similar for both the early rhythm control and usual care groups.

“We believe that these results may have a potential impact on the future use of rhythm control therapy, further improving care of our patients with atrial fibrillation. Especially including and focusing on those who have asymptomatic early atrial fibrillation and who are at risk of stroke,” Willems said during the press conference.

Results of the new analysis were simultaneously published in the European Heart Journal.

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